Prescription drug · ANDA
Ritonavir NDC 65862-687
Ritonavir 100 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-687-01 | 65862068701 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-687-01)Marketed from Sep 17, 2018 | |
| 65862-687-05 | 65862068705 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-687-05)Marketed from Sep 17, 2018 | |
| 65862-687-30 | 65862068730 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-687-30)Marketed from Sep 17, 2018 | |
| 65862-687-99 | 65862068799 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-687-99)Marketed from Sep 17, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ritonavir
- Generic name (nonproprietary)
- ritonavir
- Active ingredients
- Ritonavir — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206614
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 1A2 Inducers (Mechanism)Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 2C19 Inducers (Mechanism)Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)HIV Protease Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)UDP Glucuronosyltransferases Inducers (Mechanism)
- Identifiers
- Product ID 65862-687_35e7d4f2-b970-4126-8919-0c57d01e1e7bSPL ID 35e7d4f2-b970-4126-8919-0c57d01e1e7b
- Pharmacologic class
- Cytochrome P450 3A Inhibitor; Protease Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N465862068701followed by a unit qualifier and the quantityPackage 65862-0687-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
The FDA listing for this product does not reference a label (SPL) set.
About NDC 65862-687
- What is NDC 65862-687?
- 65862-687 is the product NDC for Ritonavir, Ritonavir 100 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ritonavir.
- What is the active ingredient?
- Ritonavir.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ritonavir?
- 6 other product NDCs are listed under this name. See all Ritonavir NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ritonavir products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ritonavir | Ritonavir 100 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-420 | 60687-0420-25 |
| Ritonavir | Ritonavir 100 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-061 | 65162-0061-0665162-0061-32 |
| Ritonavir | Ritonavir 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2610 | 71335-2610-01 |
| Ritonavir | Ritonavir 100 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3898 | 68071-3898-03 |
| Ritonavir | Ritonavir 100 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-5702 | 63629-5702-01 |
| Ritonavir | Ritonavir 100 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-597 | 31722-0597-1231722-0597-30 |
Other NDCs under ANDA 206614
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ritonavir | Ritonavir 100 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-420 |
| Ritonavir | Ritonavir 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2610 |
| Ritonavir | Ritonavir 100 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3898 |